Spectranetics under investigation
Device Regulation Alert: Safety, Compliance and Reimbursement News, September 15, 2008
The FDA and Immigration and Customs Enforcement executed a search warrant at Spectranetics, according to a company release.
- Promotion, use, testing, marketing, and sales of certain company products for the treatment of in-stent restenosis, payments made to medical personnel and an identified institution for this application
- Promotion, use, testing, experimentation, delivery, marketing, and sales of catheter guidewires and balloon catheters manufactured by certain third parties outside of the United States
- Two post-market studies completed from 2002 to 2005 and payments to medical personnel in connection with those studies
- Compensation packages for certain of the company’s personnel
In its release, Spectranetics said it is cooperating fully with investigators.
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